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O2matic-COVI: Automatic Oxygen Titration With O2matic® to Patients Admitted With COVID-19 and Hypoxemic Respiratory Failure

Sponsor
Hvidovre University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04565106
Collaborator
Innovation Fund Denmark (Other)
16
Enrollment
1
Location
1.5
Actual Duration (Months)
10.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients with coronavirus disease (COVID-19) and pneumonitis often have hypoxemic respiratory failure and a need of supplementary oxygen. Guidelines recommend controlled oxygen, for most patients with a recommended interval of SpO2 between 92 and 96 %. We aimed to determine if closed-loop control of oxygen was feasible in patients with COVID-19 and could maintain SpO2 in the specified interval.

Condition or Disease Intervention/Treatment Phase
  • Device: Closed-loop control of oxygen supplementation by O2matic

Detailed Description

Patients with coronavirus disease (COVID-19) and pneumonitis often have hypoxemic respiratory failure and a need of supplementary oxygen. Guidelines recommend controlled oxygen, for most patients with a recommended interval of SpO2 between 92 and 96 %. We aimed to determine if closed-loop control of oxygen was feasible in patients with COVID-19 and could maintain SpO2 in the specified interval.

Patients were prospectively enrolled in an observational study on a medical ward dedicated to patients with COVID-19. Closed-loop controlled oxygen was delivered by O2matic® which can deliver 0-15 liters/min and adjusts flow every second based on 15 seconds averaging of SpO2 measured by pulse oximetry. Lung function parameters were measured at admission.

Study Design

Study Type:
Observational
Actual Enrollment :
16 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Automatic Oxygen Titration With O2matic® to Patients Admitted With COVID-19 and Hypoxemic Respiratory Failure
Actual Study Start Date :
Apr 15, 2020
Actual Primary Completion Date :
May 31, 2020
Actual Study Completion Date :
May 31, 2020

Outcome Measures

Primary Outcome Measures

  1. Time in SpO2 target [1 week]

    Time in SpO2 target of 92-96 %

Secondary Outcome Measures

  1. Time with SpO2 not more than 2 % outside target [1 week]

    Time with SpO2 not more than 2 % outside target

  2. Time with SpO2 more than 2 % outside target [1 week]

    Time with SpO2 more than 2 % outside target

  3. Time with SpO2 < 85 % [1 week]

    Time with SpO2 < 85 %

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Older than 18 years

  • Positive COVID-19 PCR analysis in pharyngeal swab or in tracheal secretion

  • Need oxygen supply to maintain SpO2 ≥ 92 %

  • Able to comply with continuous measurement of SpO2 by pulse oximetry.

Exclusion Criteria:
  • Need of oxygen supply > 10 liters/min at admission

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hvidovre University Hospital Copenhagen Denmark 3550

Sponsors and Collaborators

  • Hvidovre University Hospital
  • Innovation Fund Denmark

Investigators

  • Study Chair: Ove Andersen, PhD, Hvidovre University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ejvind Frausing Hansen, Chief Physician, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT04565106
Other Study ID Numbers:
  • O2matic-COVID
First Posted:
Sep 25, 2020
Last Update Posted:
Sep 25, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ejvind Frausing Hansen, Chief Physician, Hvidovre University Hospital
O2matic
Closed-loop
Additional relevant MeSH terms:
COVID-19
Respiratory Insufficiency
Hypoxia

Study Results

No Results Posted as of Sep 25, 2020